Inserter for intra-uterine device (IUD)

ABSTRACT

The inserter is designed to receive and hold an intra-uterine device (IUD), as well as to insert the IUD in the uterus, and comprises two opposed holding members, which are U-shape in cross-section, which conjointly define an elongated tubular element which preferably is slightly bowed. At a zone intermediate the ends of the inserter, and substantially at its midpoint, the two holding members are spread apart or opened to form an IUD receiving and holding portion. In use, a cervix shield portion of the inserter is inserted into the uterus, the cervix shield portion extending from the receiving and holding portion to the inner end of the inserter, and the inner end is tapered. A plunger is then inserted in the outer end of the inserter to engage the IUD and move it through the cervix shield portion out the inner end of the inserter and into the uterus, after which the inserter is withdrawn. Elastic bands or the like hold the U-shape members in engagement with each other, to form the tubular inserter, while allowing the holding members, in the cervix shield portion, to expand to facilitate movement of the IUD therethrough. The spread apart portion of the inserter may be provided with supporting surfaces for an IUD and may have the shape of a flat trumpet.

United States Patent [191 Okamoto et a1.

[451 Nov. 11, 1975 1 1 INSERTER FOR INTRA-UTERINE DEVICE (IUD) [75]Inventors: Tadao Okamoto; Takeo Komamura,

both of Tokyo; Atsumi Ishihama, Morioka, all of Japan [30] ForeignApplication Priority Data Feb. 26, 1974 Japan 49-21984 [52] US. Cl.128/130 [51] Int. Cl. A61F 5/46 [58] Field of Search 128/127-131.

632,812 12/1949 United Kingdom 128/264 Primary E.\'aminerLawrence W.Trapp Attorney, Agent, or Firm-McGlew and Tuttle [57] ABSTRACT Theinserter is designed to receive and hold an intrauterine device (IUD),as well as to insert the IUD in the uterus, and comprises two opposedholding members, which are U-shape in cross-section, which conjointlydefine an elongated tubular element which preferably is slightly bowed.At a zone intermediate the ends of the inserter, and substantially atits midpoint, the two holding members are spread apart or opened to forman IUD receiving and holding portion.

In use, a cervix shield portion of the inserter is inserted into theuterus, the cervix shield portion extending from the receiving andholding portion to the inner end of the inserter, and the inner end istapered. A plunger is then inserted in the outer end of the inserter toengage the IUD and move it through the cervix shield portion out theinner end of the inserter and into the uterus, after which the inserteris withdrawn. Elastic bands or the like hold the U-shape members inengagement with each other, to form the tubular inserter, while allowingthe holding members, in the cervix shield portion, to expand tofacilitate movement of the IUD therethrough. The spread apart portion ofthe inserter may be provided with supporting surfaces for an IUD and mayhave the shape of a flat trumpet.

8 Claims, 17 Drawing Figures U.S. Pat6nt Nov. 11, 1975 Sheet 1 of53,918,445

FIG. I

U.S. Patent Nov 11, 1975 Sheet 2 of5 3 918 445 FIG. 7

US. Patent Nov. 11, 1975 Sheet 3 of5 3,918,445

FIG. /5

FIG. /7

FIG. /6

US. Patent Nov.11, 1975 Sheet4of5 3,918,445

FIG. 9

US, Patent Nov. 11,1975 Sheet50f5 3,918,445

INSERTER FOR INTRA-UTERINE DEVICE (IUD) FIELD AND BACKGROUND OF THEINVENTION This invention relates to contraceptive appliances forpreventing the fertilized ovum from being deposited on the bed of theuterus by inserting an intra-uterine de vice (IUD) made of syntheticresin into the uterus and, more particularly, to a novel and improvedinserter enabling a user to insert and set the IUD in the uterus bysetting the IUD in the inserter beforehand and using a plunger to pushthe IUD through the inserter and out the inner end thereof into theuterine cavity.

There are conventional devices of this kind, such as loop and Dalkontypes, in a ring form. For inserting such contraceptive devices into theuterus, the cervix must be expanded and the cervix tends to be harmedoften by such expansion. As a consequence, many users may suffer fromsuch harmful effects as pain and bleed- There are some other improveddevices which are not in a ring form, and which are still incapable ofstoring an IUD beforehand, due to lack of full restoration of theoriginal shape of the synthetic resin IUD. Thus, an IUD must be set,just before insertion into the uterus, into the tube of such a device bypulling threads attached to the IUD. The IUD is then inserted and set inthe uterine cavity by means of a cylinder.

SUMMARY OF THE INVENTION The invention is directed to an inserter for anintrauterine device (IUD) for contraceptive use, in which theinconveniences of prior art devices are eliminated. For the sake ofbrevity the term IUD will be used, hereinafter, to designate anintra-uterine device.

An objective of the invention is to provide an IUD inserter by means ofwhich it is possible to insert an IUD into the uterus instantly withoutmechanical harm to the cervix, merely by introducing a plunger into theinserter in which the IUD has already been set.

Another objective is to provide an inserter into which an IUD may be setand kept in its original form, so as to be used without undesireddeformation even after a long period of storage.

In further accordance with the invention, the inserter has a cervixshield portion at its leading end formed of two opposed members, ofU-shape cross-section arranged in facing engagement in such a manner asto be freely spread apart to some extent for feeding an IUD through thecervix shield portion, with the IUD being expanded as it passes throughthe cervix shield portion .without' causing any mechanical injury to thecervix.

For the purpose of receiving an IUD, the inserter has, intermediate itsends, a spread apart or open IUD receiving and holding portion shapedand adapted to hold various types of IUDs, different in shape and size,firmly therein and permitting easy insertion of the IUD into the cervixshield portion of the inserter.

A further object of the invention is to provide such an inserter whichenables a user to insert an IUD properly in the uterus without the useof any probe, by making good use of an interrelation in length betweenthe inserter and a plunger for inserting the IUD.

For an understanding of the principles of the invention, reference ismade to the following description of typical embodiments thereof asillustrated in the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings:

FIG. 1 is a front elevational view, partly cutaway, of an inserterembodying the invention;

FIG. 2 is a side view, partly cut away, of the inserter shown in FIG. 1;

FIG. 3 is an end elevation view taken along the line III-III of FIG. 2,looking in the direction of the arrows;

FIG. 4 is an end elevation view, taken along the line IVIV of FIG. 3,looking in the direction of the arrows;

FIG. 5 is a front elevation view, partly broken away, of a plunger foruse with the inserter;

FIG. 6 is an end elevation view, taken along the line VIVI of FIG. 5,looking in the direction of the arrows;

FIG. 7 is a front elevation view, partly cut away, of a spread or openportion of the inserter;

FIG. 8 is a front elevation view of an IUD;

FIG. 9 is an exploded perspective view of another in serter embodyingthe invention, and its associated plunger;

FIG. 10 is a front elevation view, partly broken away, of the spread oropen portion of the inserter shown in FIG. 9;

FIG. 11 is a transverse sectional view taken on the line XI-XI of FIG.10 and looking in the direction of the arrows;

FIG. 12 is a front elevation view, partly broken away, of the spread oropen portion of still another inserter embodying the invention;

FIG. 13 is a transverse sectional view, taken along the line XIIIXIII ofFIG. 12, looking in the direction of the arrows;

FIG. 14 is a front elevational view of another form of IUD;

FIG. 15 is a side elevation view of the IUD shown in FIG. 14;

FIG. 16 is an explanatory view illustrating the use of the inserter andshowing an IUD just before the setting thereof in the utuerus; and

FIG. 17 is a view similar to FIG. 16 and illustrating the setting of theIUD in the uterus.

DESCRIPTION OF THE PREFERRED EMBODIMENTS As previously mentioned, thepresent invention is directed to an inserter for an IUD, such as acontraceptive ring. In conventional inserters, such a ring device mustbe set therein at each time a ring device is to be inserted, and inpractice, this is very troublesome. The invention is accordinglydirected to an inserter which provides for previous setting of an IUD inthe inserter, before use of the IUD, and immediate setting of the IUDinto the uterus simply by inserting a plunger through the inserter tomove the IUD out of the inner end of the inserter and into the uterus.

In accordance with the invention, as shown in FIGS. 1 through 8, aninserter l for an IUD, such as a contraceptive ring, has a spread oropen portion 2 provided at about its midportion, this spread or openportion being formed by two holding members c'and d arranged inopposition to each other and U-shape in crosssection for holding theIUD, such as a contraceptive ring. With the inserter of the invention,an IUD 9, shown in FIG. 8, can be set beforehand or stored in the spreadportion 2 of the inserter 1. Inserter 1 has the general form of a tube,being formed by two members a and [2 arranged in facing opposition so asto form the tube, the members a and [2 having a U-shape crossscction.These members are maintained in firm but releasable engagement with eachother by rubber rings r, while, at the entrance for a plunger, the twomembers are maintained in firm engagement with each other by means of aholding ring 3. The setting exit portion 4 of the inserter is tapered soas to be inserted easily into the vagina.

As best seen in FIG. 2, inserter 1 preferably is slightly arcuate, so asto make a users posture, during insertion of the IUD, easy for theinsertion. In order to insert the IUD into the uterus, the inserter isput into the vagina up to the line 11 in FIG. 1, whereby the exit orinner end of the inserter will contact the fundus uteri. A plunger 5,shown more particularly in FIGS. 5 and 6, is introduced into theinserter through the holding ring 3 so as to push the IUD 9 on the tipof the plunger into the uterus. Plunger 5 has a support 6, for the IUD,on the leading end ofa bar 7, the support 6 receiving a vertical shaftportion of the IUD 9. The IUD 9 is inserted into the uterus with theassistance of a grip 8 on the outer end of the plunger 5.

The IUD 9 used with the inserter shown in FIGS. 1 through 7 isillustrated, in FIG. 8, as shaped like an inverted unfolded fan,preferably including the vertical shaft 10 having branches 1] extendingtherefrom. However, the structure of the IUD is not limited to the shapeshown in FIG. 8, but the IUD may have any other form so long as it canbe held between the holding members 0 and d of the spread portion 2 ofthe inserter l, and can be pushed out by means of plunger 5.

When the IUD is pushed by the plunger through the forward or innerportion of the inserter 1, the branches 11 are folded inwardly as shownby the dotted lines in FIG. 8. When the IUD is forced out of the settingexit 4 and inserted into the uterus, the branches l1 spread apart andare set stably in the uterus to conform substantially to the uterineshape as shown by solid lines in FIG. 8.

Upon completion of the insertion of the IUD into the uterus, inserter lis withdrawn from the vagina and the IUD is left in the uterus. Forremoving the IUD from the uterus, there are used threads which have beenpreviously attached to the IUD.

The IUD inserter embodying the invention has numerous advantages. Thus,inserter 1, containing an IUD beforehand, may be sold as a compositearticle, permitting simple insertion of the IUD into the uterus by justinserting plunger 5 into the inserter. Furthermore, the IUD ismaintained safe against deformation before its sale due to the shape ofthe spread portion 2, which is adapted to that of the IUD. If an IUDformed of synthetic resin is stored in a cylindrical case, notconforming to the shape of the IUD, the IUD may be deformed, after thelapse of some time, due to permanent deformation of the synthetic resinmaterial, and may not resume its original shape or form. This means afailure of the essential function of the IUD.

In a prior art IUD inserter having a tubular inserting portion, an IUD,when used, is set in the cervix shield portion of the inserter bypulling or pushing the IUD thereinto while deforming the IUD. Underthese conditions, the inserter is placed into the uterus, and the IUD ispushed into the uterus from the inserter with a bar,

from under the shield portion.

By contrast, with the present invention, an IUD can be previouslycarried in a position outwardly of the cer- 5 vix shield portion of theinserter and without deformation, and the plunger may be easily insertedinto the inserter when it is desired to use the IUD. Thus, an advantageof the invention arrangement is that it is very convenient to use theinserter as it does not require troublesome setting by pulling orpushing an IUD thereinto each time an IUD is to be used,

A further advantage of the invention is that, when an IUD is beinginserted into the uterus, the cervix is protected from any mechanicalinjury which otherwise might occur, as a result of the passing of theIUD through the interior of the cervix shield portion and into theuterus.

In accordance with a further feature of the invention, a supportingsurface 12, as shown in FIGS. 1 through 7, is provided at the locationwhere the holding members c and d, forming the spread portion 2, engageeach other, this supporting surface having a proper area for supportingthe IUD. Supporting surface 12 extends in a plane from the inner side ofeither of the holding members forming the spread portion 2, so as tohold an IUD more positively. Portion 12 further serves to protect storedIUDs, which may be different in shape and size, against accidentallyfalling out of the inserter. The area of the supporting face 12 may bedefined as such as to span the space between holding members c and d,with the supporting surface 12 extending from either of these holdingmembers.

Furthermore, in other embodiments of the invention as shown in FIGS. 12and 13, an IUD can be guided into the cervex shield portion of theinserter more positively. In these figures, guide plates 13 are providedin the form of a flat trumpet at the joining positions of the holdingmembers 0 and d. The guide plates 13 are formed at the entrance into theshield portion 1', so as to hold an IUD 9, set in spread portion 2, withthe leading end engaged with the cervix shield portion, and therebyprotecting the IUD from slipping as well as keeping it secured inposition independent of its size and shape. The guide plates 13 alsoserve as an effective means for guiding and pushing an IUD 9, when used,into cervix shield portion 1, smoothly and without fail by engaging theleading end 6 of the plunger 5 with the stem portion of the IUD.

As shown in the embodiments of the invention illustrated in FIGS. 1, 9and 12, shield portion 1 is formed like a tube by engaging the twoopposed members a and b, and these members are elastically retained intoengagement so as to be expandable or spreadable to a certain extent. Inthe embodiment of FIG. 2, the opposed members a and b are retained inengagement by means of rubber rings r, so as to permit some spreadingthereof and smooth passage of an IUD, in accordance with the form andsize of the IUD.

On the other hand, in the embodiment of the invention shown in FIGS. 9and 12, shield portion 1' is inserted slidably through a slot 14 on aframe 15 which has a fixed bearing piece 16 extending therefrom andcooperable with an opposed movable bearing piece 17. Bearing pieces 16and 17 are elastically retained in engagement with each other by arubber band r so that movable bearing piece 17 is elasticallydisplaceable relative to fixed bearing piece 16. Bearing pieces 16 and17 are engaged and supported in such'a manner as to embrace the twoopposed members .a and b. An IUD may pass through the tubular cervixshield portion thus formed by the members a and b.

In conventional inserters, which are of a simple tubular form, use ofdifferent IUDs is limited by the diameter of the shield portion. Inaccordance with the present invention, the shield portion is spreadableor expandable laterally, so that limitation due to the difference insize between IUDs is eliminated. It is thus possible to set an IUD inthe uterus without mechanical harm to the cervix uteri by inserting theshield portion of the inserter through the cervix, with the shieldportion compressed, feeding the IUD from the rear or outer end of theshield portion, and passing the IUD through the shield portion while thelatter is expanded or spread. Thus, the inserter embodying thisinvention has a wider and more useful application.

In the embodiment of the invention shown in FIG. 9, the opposed membersa and b are provided, at their respective leading ends, with a recess 18and a protrusion 19, each protrusion on one member being engageable intoa recess on the other member. This reinforces the shield portion, aswell as prevents the shield portion from undesired distortion or axialmisengagement as a result of the spreading of the shield portion at thetime of insertion of the IUD into the uterus.

In this embodiment of the invention, marks 20 are provided for measuringthe length of the insertion. In the embodiment of FIG. 1, on the otherhand, the mark to indicate the insertion depth is the position of therubber ring r furthest from the spread portion 2. In the embodiment ofFIG. 9, an indication plate 21 is wound around the inserter.

As illustrated in FIGS. 14 and 15, an IUD of synthetic resin has holes22 for the pulling threads, and these are positioned in a recessedportion 23 of the inserter shown in FIG. 10, for drawing the pullingthreads outside.

A further object of the present invention is to provide an inserterwhich permits proper spreading of an IUD in the uterine cavity withoutthe use of any probe. FIGS. 9, l6 and 17 illustrate how this isaccomplished in practice. In FIG. 9, a point P, close to grip 8 onplunger 5, is used as a reference point, plunger 5 having the samelength as inserter l, and a point Q is marked, at a position spaced frompoint P, by the length L of an IUD and in the forward axial direction.

In practical use, the shield portion of inserter l is inserted towardthe uterus until' its inner or leading end strikes against the fundusuteri R, illustrated in FIGS.

16 and 17, and plunger 5 is introduced into the inserter 1 until point Qis aligned with the outer end of inserter 1. At this time, the leadingor inner end of plunger 5 has pushed an IUD 9 to the inner end of shieldportion 1', where the leading end of the IUD is brought into contactwith the fundus uteri R. Inserter 1 is now drawn back to the point ormarking P on plunger 5, so that shield portion 1 is retracted from thefundus uteri R by the length L with plunger 5 being maintainedstationary. As a result, the IUD is released from the setting exit 4 ofthe inserter 1 and remains in the uterus.

By contrast with the present invention, for setting an IUD properly inthe uterus, that is, right against the fundus uteri, in conventionalinserters, the distance must be measured by the use of a probe beforeinsertion of the IUD, after which the IUD is inserted so as to engageagainst the fundus uteri. Such an operation cannot be carried out withexternal direct perception.

On the other hand, with the arrangement of the present invention and itsoperation as described above, it is possible to operate the inserterquite in the same way and with visual perception of the actual stateinside the shield portion, and to set the IUD in proper position in theuterine cavity.

While specific embodiments of the invention have been described indetail to illustrate the application of the principles of the invention,the invention may be embodied otherwise without departing from suchprinciples.

What is claimed is:

1. An inserter for an intra-uterine device for contraceptive usecomprising, in combination, a pair of elongated continuous and facingsubstantially U-shape cross-section members forming an elongatedintrauterine device holding and guiding element, said members beingspaced apart only at a relatively short zone intermediate their ends toform a widened receiving and holding portion for an expanded IUD,'saidreceiving and holding portion being constituted by two opposed andlaterally spaced coextensive and uninterrupted intermediate portions ofsaid continuous U- shape cross-section members which latter areotherwise in contact with each other throughout the length of saidholding and guiding element.

2. An inserter, as claimed in claim 1, including a cervix shield portionextending from said receiving and holding portion and communicatingtherewith; said cervix shield portion being constituted by uninterruptedportions of said two U-shape cross-section members forming a tube; andmeans retaining said lastnamed portions of said members in engagementwith each other.

3. An inserter, as claimed in claim 2, in which said retaining meanscomprises at least one resilient member embracing said cervix shieldportion forming portions of said members to provide for elastic lateralspreading thereof to some extent.

4. An inserter, as claimed in claim 3, including a tubular plungerguiding portion extending outwardly from said receiving and holdingportion to receive and guide a plunger into engagement with anintra-uterine device received and held in said receiving and holdingportion to move the intra-uterine device into, through and out of saidcervix shield portion.

5. An inserter, as claimed in claim 4, in which said receiving andholding portion includes a supporting surface extending thereacrossbetween said spaced apart portions of said members.

6. An inserter, as claimed in claim 4, in which the junction betweensaid receiving and holding portion and said cervix shield portion isshaped like a flattened trumpet.

7. An inserter, as claimed in claim 4, including an elongated plungerinserted through said holding and guiding element to engage anintra-uterine device to move the device from said receiving and holdingportion into, through and out of said cervix shielding portion; saidplunger having an outer manipulating end and an inner end engageablewith an intra-uterine device in said receiving and holding portion; saidplunger having, adjacent its outer end and at a point spaced from itsinner end by a distance equal to the length of said holding and guidingelement, a first reference 3 ,9l 8,445 7 8 mark, and having. at adistance inwardly from said first 8. An inserter, as claimed in claim 4,in which said reference mark equal to the length of an intra-uterinedevice. a second reference mark; said plunger being insorted throughsaid holding and guiding element up to said first reference mark.

cervix shield portion has thereon at least one reference mark indicatingthe depth of insertion.

k l l

1. An inserter for an intra-uterine device for contraceptive usecomprising, in combination, a pair of eloNgated continuous and facingsubstantially U-shape cross-section members forming an elongatedintra-uterine device holding and guiding element, said members beingspaced apart only at a relatively short zone intermediate their ends toform a widened receiving and holding portion for an expanded IUD, saidreceiving and holding portion being constituted by two opposed andlaterally spaced coextensive and uninterrupted intermediate portions ofsaid continuous Ushape cross-section members which latter are otherwisein contact with each other throughout the length of said holding andguiding element.
 2. An inserter, as claimed in claim 1, including acervix shield portion extending from said receiving and holding portionand communicating therewith; said cervix shield portion beingconstituted by uninterrupted portions of said two U-shape cross-sectionmembers forming a tube; and means retaining said last-named portions ofsaid members in engagement with each other.
 3. An inserter, as claimedin claim 2, in which said retaining means comprises at least oneresilient member embracing said cervix shield portion forming portionsof said members to provide for elastic lateral spreading thereof to someextent.
 4. An inserter, as claimed in claim 3, including a tubularplunger guiding portion extending outwardly from said receiving andholding portion to receive and guide a plunger into engagement with anintra-uterine device received and held in said receiving and holdingportion to move the intra-uterine device into, through and out of saidcervix shield portion.
 5. An inserter, as claimed in claim 4, in whichsaid receiving and holding portion includes a supporting surfaceextending thereacross between said spaced apart portions of saidmembers.
 6. An inserter, as claimed in claim 4, in which the junctionbetween said receiving and holding portion and said cervix shieldportion is shaped like a flattened trumpet.
 7. An inserter, as claimedin claim 4, including an elongated plunger inserted through said holdingand guiding element to engage an intra-uterine device to move the devicefrom said receiving and holding portion into, through and out of saidcervix shielding portion; said plunger having an outer manipulating endand an inner end engageable with an intra-uterine device in saidreceiving and holding portion; said plunger having, adjacent its outerend and at a point spaced from its inner end by a distance equal to thelength of said holding and guiding element, a first reference mark, andhaving, at a distance inwardly from said first reference mark equal tothe length of an intra-uterine device, a second reference mark; saidplunger being inserted through said holding and guiding element up tosaid first reference mark.
 8. An inserter, as claimed in claim 4, inwhich said cervix shield portion has thereon at least one reference markindicating the depth of insertion.